CN102247338A - Composite of glycerol and fructose - Google Patents
Composite of glycerol and fructose Download PDFInfo
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- CN102247338A CN102247338A CN2011101415215A CN201110141521A CN102247338A CN 102247338 A CN102247338 A CN 102247338A CN 2011101415215 A CN2011101415215 A CN 2011101415215A CN 201110141521 A CN201110141521 A CN 201110141521A CN 102247338 A CN102247338 A CN 102247338A
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Abstract
The invention relates to a composite of glycerol and fructose, which is characterized in that the preparation comprises the following components in parts by weight of the use amount of 1000 bottles: 25kg of glycerol, 12.5kg of fructose, 2.25kg of sodium chloride and the balance of injection water added to 250000 ml. The preparation can achieve the function of effectively lowering intracranial pressure, has long duration and avoids bounce; meanwhile, urine volume is obviously lower than patients applying mannitol, and the burden of the kidney is lightened; certain energy is provided; and thus the composite is especially suitable for patients suffering from long-term coma.
Description
Technical field
The present invention relates to the drug combination injection of a kind field of medicine preparing technology, specifically a kind of glycerol and fructose composite.
Background technology
In the prior art, glycerol and fructose injection mainly are applicable to the acute and chronic intracranial hypertension that cerebrovascular, cerebral trauma, the cerebral tumor, intracranial inflammation and other reasons cause, diseases such as cerebral edema.It is the modal disease of neurosurgery that cranium is pressed height, be to use mannitol to treat for a long time clinically always, respond well, but it has many side effect such as rebound phenomenon, electrolyte disturbance, renal function injury, use the glycerol blood pressure lowering from U.S. Virno in 1961, fail extensively to promote because of it has the haemolysis side effect.Compatibility agent research to glycerol since the eighties has obtained great success, adds fructose and can reduce its haemolysis side effect in glycerol.Clinical research shows that the clinical symptoms of glycerin and fructose injection treatment intracranial hypertension all has improvement in various degree, and does not have rebound phenomenon, the injection back after 0.6 ± 0.35 hour intracranial pressure begin to descend, the blood pressure lowering peak is about 2 hours, sustainable about 6 hours.The urine amount increases not obvious, the specific gravity of urine no change, and the clinical assay electrolyte does not get muddled.Clinical trial proves, uses glycerin and fructose injection that cranium is pressed high patient to dewater to fall cranium and presses treatment can obtain effect preferably.Chinese patent literature discloses many pieces of application for a patent for invention Publication Specifications such as CN101327200A, CN101632681A; Case from these document records at the caused clinical sign of brainpan disease, all has effective active responding behind the prescribed dose medicine that has used open source literature to provide, this explanation inventor's creation invention has certain practicality.Yet, thereby find how to improve the component of glycerol and fructose composite in the practice and preparation method raising brainpan disease patient's clinical therapeutic efficacy is still the current excelsior problem that remains.
Summary of the invention
The objective of the invention is to provide a kind of glycerol and fructose composite, in the hope of solving the essence amount component and the stability of drug problem of drug combination injection.
For this reason, the technical scheme that the present invention solves described problem is: a kind of glycerol and fructose composite is characterized in that described preparation has by 1000 bottles of its weight portions of consumption:
And, the preparation method of a kind of glycerol and fructose composite, wherein, described method is by step:
(1) takes by weighing glycerol, fructose, the sodium chloride of recipe quantity, place in the suitable sterile chamber; (2) add the injection water, stir and make its dissolving; (3) add needle-use activated carbon (0.08%), stir, keep little boiling (100 ℃) 15min, use titanium filter stick decarbonization filtering while hot; (4) benefit adds to the full amount of water for injection, and regulating pH value with the hydrochloric acid solution of 0.1mol/L is 3.0-6.0, filters with φ 0.22 μ m, φ 0.45 μ m twice microporous filter membrane, carries out intermediate and measures (content and pH value); (5) measure qualified after, lid is rolled in fill; (6) high temperature sterilize.
Compared to existing technology, substantive distinguishing features that the present invention has and significant technological progress are taken off clever at current goods: goods of the present invention can reach the intracranial pressure effect that effectively reduces, longer duration does not have knock-on, and the urine amount is starkly lower than the patient who uses mannitol simultaneously.The diuresis of its goods is starkly lower than formula mannitol injection liquid, can alleviate the kidney burden simultaneously, also can provide certain energy, and is particularly suitable to the patient of long-term stupor.But its goods be a kind of safe and reliable, prolonged application that has no side effect cranium pressing thing falls.
The specific embodiment
The present invention relates to a kind of glycerol and fructose composite, wherein, described preparation has by 1000 bottles of its weight portions of consumption:
The preparation method of a kind of glycerol and fructose composite, wherein, described method comprises step:
(1) takes by weighing glycerol, fructose, the sodium chloride of recipe quantity, place in the suitable sterile chamber;
(2) add the injection water, stir and make its dissolving;
(3) add needle-use activated carbon (0.08%), stir, keep little boiling (100 ℃) 15min, use titanium filter stick decarbonization filtering while hot;
(4) benefit adds to the full amount of water for injection, and regulating pH value with the hydrochloric acid solution of 0.1mol/L is 3.0-6.0, filters with φ 0.22 μ m, φ 0.45 μ m twice microporous filter membrane, carries out intermediate and measures (content and pH value);
(5) measure qualified after, lid is rolled in fill;
(6) high temperature sterilize.
Specifically, prescription of the present invention is according to being: according to clinical manifestation, intracranial hypertension makes cerebral circulation generation obstacle, increases the weight of cerebral ischemia and cerebral edema, and the probability that cerebral hernia is formed increases and jeopardizes patient's life, needs to treat with dehydrated pharmaceutical.In decades, mannitol is that the medicine that cranium is pressed effectively falls in strong that neurosurgery is used always, but its blood pressure lowering persistent period is short, rebound phenomenon is arranged, a large amount of inputs might cause renal damage, are suitable for rescuing acute intracranial hypertension person or cerebral hernia person, but unsuitable long-term heavy dose of the use.And need select long action time for use to the clinical patients of non-acute intracranial hypertension, no rebound phenomenon, the medicine little to renal damage.In view of the above, clinical research shows that glycerol of the present invention and fructose combination composition injection all have improvement in various degree when the clinical symptoms of treatment intracranial hypertension, and does not have rebound phenomenon, the injection back after 0.6 ± 0.35 hour intracranial pressure begin to descend, the blood pressure lowering peak is about 2 hours, sustainable about 6 hours.The urine amount increases not obvious, the specific gravity of urine no change, and the clinical assay electrolyte does not get muddled.
For this reason, the present invention has carried out the preferred of preparation process condition:
1, the pH value of injection:
Claim that according to listing product glycerin and fructose injection fixed pH value scope is 3.0～6.0, so the pH value of this product also is decided to be 3.0～6.0.By influence factor, study on the stability, this product is all stable in this pH value scope.
2, charcoal test:
In order to guarantee product quality, decolouring and depyrogenation, select the needle-use activated carbon absorption of 0.02% and 0.05% (g/ml), investigate the absorption situation of active carbon to this product principal agent.Result of the test sees the following form 1.
Table 1 needle-use activated carbon is to the result of the test of this product principal agent absorption
As seen from the experiment, needle-use activated carbon does not adsorb substantially to glycerol, fructose, sodium chloride, and therefore 0.08% activated carbon adsorption system easy to control the quality selects 0.08% activated carbon dosage in technological operation.
The present invention has also further done the investigation about its stability influence factor of related compositions:
1. accelerated test
Get trial-production three batch samples by commercially available back, put in the calorstat, under 40 ± 5 ℃ of temperature, relative humidity 75% ± 5% condition, placed 6 months, 1st month, 2 months, 3 months, 6 samplings at the end of month once, sample character, pH value, clarity, 5 hydroxymethyl furfural, related substance and content are investigated respectively.Result of the test sees Table 2.
Table 2 glycerin and fructose injection accelerated test result
Its conclusion is: preparation of the present invention is pressed commercially available back, accelerated test 6 months, and every index and relatively do not have significant change and steady quality in 0 day, packing are rationally.
In addition, the present invention has further done scale-up:
Feed intake for 250 times by recipe quantity, manufacture experimently three batch samples according to preparation technology, the result is as follows:
The present invention has further done clinical efficacy relatively besides:
Began to use glycerin and fructose injection treatment acute cerebrovascular disease 46 examples from 2002, now relevant result reported as follows:
Case is selected: in January, 2002 to June is in the inpatient of institute totally 46 examples, cerebral infarction 38 examples wherein, cerebral hemorrhage 8 examples.24 examples are organized in treatment, matched group 22 examples.All make a definite diagnosis 34～80 years old age, 65.5 years old mean age through CT.
Medication: treatment group: glycerin and fructose injection 250～500ml intravenous drip,
Table 1: observe with the high relevant clinical sign of intracranial pressure
Every day 1～2 time, logotype 7～10 days.Matched group: 20% mannitol, 125～250ml intravenous drip, every day 2～4 times, logotype 7～10 days.
Merge and the taboo medicine: the conventional use of the required medicine of treatment protopathy, forbidding hormone and other diuresis dehydrated pharmaceuticals during the medication.
Clinical sign after the medication (headache, consciousness, blood pressure, vomiting) and the index (hemiplegia, aphasia) relevant with constitutional all have improve (seeing Table 1,2) in various degree.The treatment group is to blood glucose, renal function (BUN, Cr), electrolyte (Na, K
+, Cl
-, Ca
++), hemoglobin, erythrocyte, reticulocyte count, urobilinogen and serum bilirubin do not have influence, matched group can cause renal insufficiency, electrolyte disturbance (seeing Table 3).
Table 2: the observation index relevant with protopathy
Table 3: blood electrolyte, renal function contrast therapy group (example) matched group (example)
From above clinical treatment result as can be seen, glycerol that the present invention relates to and fructose composite preparation can reach the intracranial pressure effect that effectively reduces, and longer duration does not have knock-on, and the urine amount is starkly lower than the patient who uses mannitol simultaneously.This illustrates that its diuresis of preparation of the present invention is starkly lower than formula mannitol injection liquid, can alleviate the kidney burden simultaneously, also can provide certain energy, and is particularly suitable to the patient of long-term stupor.But glycerol that the present invention relates to and fructose composite preparation be a kind of safe and reliable, prolonged application that has no side effect cranium pressing thing falls.
Claims (2)
1. glycerol and fructose composite is characterized in that described preparation has by 1000 bottles of its weight portions of consumption:
2. glycerol according to claim 1 and fructose composite preparation is characterized in that, described preparation by the preferred resize ratio of the glycerol of 1000 bottles of its weight portions of consumption, fructose, sodium chloride be respectively ± 7%, ± 7%, ± 10%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101415215A CN102247338A (en) | 2010-05-20 | 2010-05-20 | Composite of glycerol and fructose |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101415215A CN102247338A (en) | 2010-05-20 | 2010-05-20 | Composite of glycerol and fructose |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2010101774641A Division CN101836997B (en) | 2010-05-20 | 2010-05-20 | Glycerol/fructose composite and preparation method thereof |
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| CN102247338A true CN102247338A (en) | 2011-11-23 |
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| CN2011101415215A Pending CN102247338A (en) | 2010-05-20 | 2010-05-20 | Composite of glycerol and fructose |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488696A (en) * | 2011-12-30 | 2012-06-13 | 南京正大天晴制药有限公司 | Glycerin-fructose composition injection and its preparation method |
| CN103417568A (en) * | 2013-08-08 | 2013-12-04 | 张志英 | Glycerin fructose sodium chloride injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
-
2010
- 2010-05-20 CN CN2011101415215A patent/CN102247338A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488696A (en) * | 2011-12-30 | 2012-06-13 | 南京正大天晴制药有限公司 | Glycerin-fructose composition injection and its preparation method |
| CN103417568A (en) * | 2013-08-08 | 2013-12-04 | 张志英 | Glycerin fructose sodium chloride injection and preparation method thereof |
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Application publication date: 20111123 |